REVISION OF APPROVAL PROCEDURES FOR HUMAN MEDICINES USE WITHIN WAEMU: WHAT EVOLUTION?

Abstract

The harmonization of pharmaceutical regulations has made it possible to provide UEMOA Member States with a corpus of texts, which has been revised. The objective of this study was to describe the new UEMOA regulations relating to approval procedures for medicines for human use in order to highlight the developments changes. The study material consisted of the harmonized legal texts of UEMOA, in particular the regulations relating to approval procedures. The method used consisted of analyzing the new harmonized texts from 2020 to 2022, in particular, regulation n°04/2020/CM/UEMOA with regard to the old regulations; and comparing the procedures and contents of the files. The organs involved in the approval procedure have been maintained. The National Pharmaceutical Regulatory Authority acts in place of the Minister responsible for health for applications and the issuance of Market Authorization. The new regulation defines Improved Traditional Medicines without providing for a specific approval procedure. The content of the approval application file is more detailed. In addition to the approval fees introduced in 2010, regulation No. 04/2020/CM/UEMOA introduces penalties and changes several minor variations into major variations. The processing time for market authorization applications is extended from 120 days to a range of 120 to 360 days. Finally, the new regulation n°04/2020/CM/UEMOA improves the approval procedure for medicines for human use in UEMOA Member States, which must continue harmonization efforts by showing diligence in assessing applications for approval.